Full Press Release Details
CONSOLIDATED FINANCIAL STATEMENTS
OF JUNE 30, 2022 AND DECEMBER 31, 2021
FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2022 AND 2021
CONSOLIDATED FINANCIAL STATEMENTS
OF JUNE 30, 2022 AND DECEMBER 31, 2021
FOR THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2022 AND 2021
TO CONSOLIDATED FINANCIAL STATEMENTS
| Page | |
| Condensed Consolidated Balance Sheets | F-2 |
| Condensed Consolidated Statements of Operations and Comprehensive Loss | F-3 |
| Condensed Consolidated Statements of Changes in Shareholders' Equity | F-4 |
| Condensed Consolidated Cash Flow Statements | F-5 |
| Notes to the Condensed Consolidated Financial Statements | F-6 |
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
dollars in thousands (except share data)
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 20,151 | $ | 11,202 | ||||
| Short term deposits | 42,334 | 10,004 | ||||||
| Marketable securities | - | 62,924 | ||||||
| Prepaid expenses and other receivables | 2,453 | 2,199 | ||||||
| Cash held with respect to CVR Agreement | 113 | 113 | ||||||
| Total Current Assets | 65,051 | 86,442 | ||||||
| Non-Current Assets | ||||||||
| Property and equipment, net | 6,517 | 2,530 | ||||||
| Other assets | 5,773 | 6,174 | ||||||
| Total Non-Current Assets | 12,290 | 8,704 | ||||||
| TOTAL ASSETS | $ | 77,341 | $ | 95,146 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current Liabilities | ||||||||
| Accounts payable trade | $ | 667 | $ | 878 | ||||
| Accrued expenses and other liabilities | 3,433 | 3,727 | ||||||
| CVR holders | 113 | 113 | ||||||
| Total Current Liabilities | 4,213 | 4,718 | ||||||
| Non-Current Liabilities | ||||||||
| Other long-term Liabilities | 4,642 | 5,389 | ||||||
| Total Non-Current Liabilities | 4,642 | 5,389 | ||||||
| Commitments and Contingent Liabilities | ||||||||
| TOTAL LIABILITIES | 8,855 | 10,107 | ||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Ordinary shares of NIS 0.4 par value: Authorized: 45,000,000 shares as of June 30, 2022 and December 31, 2021; Issued and outstanding: 18,381,052 and 18,331,507 as of June 30 and December 31, 2021; | 2,113 | 2,107 | ||||||
| Additional paid in capital | 135,375 | 133,796 | ||||||
| Foreign currency translation adjustments | 1,101 | 1,101 | ||||||
| Accumulated deficit | ( 70,103 | ) | ( 51,965 | ) | ||||
| TOTAL SHAREHOLDERS' EQUITY | 68,486 | 85,039 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 77,341 | $ | 95,146 |
accompanying notes are an integral part of the condensed consolidated financial statements.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
dollars in thousands (except share and per share data)
| For the three months ended | For the six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 4,110 | 2,539 | 8,792 | 5,036 | ||||||||||||
| General and administrative expenses | 1,761 | 1,269 | 3,483 | 2,574 | ||||||||||||
| 5,871 | 3,808 | 12,275 | 7,610 | |||||||||||||
| Operating loss | ( 5,871 | ) | ( 3,808 | ) | ( 12,275 | ) | ( 7,610 | ) | ||||||||
| Other income/(expense), net | ( 4,042 | ) | 700 | ( 5,863 | ) | 1,302 | ||||||||||
| Net (loss) | ( 9,913 | ) | ( 3,108 | ) | ( 18,138 | ) | ( 6,308 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Exchange differences arising from translating financial statements from functional to presentation currency | - | 2,055 | - | ( 733 | ) | |||||||||||
| Total other comprehensive income (loss) | - | 2,055 | - | ( 733 | ) | |||||||||||
| Total comprehensive (loss) | $ | ( 9,913 | ) | $ | ( 1,053 | ) | $ | ( 18,138 | ) | $ | ( 7,041 | ) | ||||
| Basic & diluted (loss) per share | $ | ( 0.54 | ) | $ | ( 0.17 | ) | $ | ( 0.99 | ) | $ | ( 0.36 | ) | ||||
| Weighted average number of shares outstanding | 18,375,206 | 18,305,882 | 18,372,521 | 17,397,860 |
accompanying notes are an integral part of the condensed consolidated financial statements.
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (UNAUDITED)
dollars in thousands (except share data)
| Ordinary Shares | Additional paid in | Currency translation | Accumulated | |||||||||||||||||||||
| Shares | Amount | capital | reserve | deficit | Total | |||||||||||||||||||
| Balance as of December 31, 2021 | 18,331,507 | $ | 2,107 | $ | 133,796 | $ | 1,101 | $ | ( 51,965 | ) | $ | 85,039 | ||||||||||||
| Changes during the three months period ended March 31, 2022: | ||||||||||||||||||||||||
| Restricted stock units vested | 34,295 | 4 | ( 4 | ) | - | - | - | |||||||||||||||||
| Exercise of options | 7,625 | 1 | 49 | - | - | 50 | ||||||||||||||||||
| Stock based compensation | - | - | 788 | - | - | 788 | ||||||||||||||||||
| Net loss | - | - | - | - | ( 8,225 | ) | ( 8,225 | ) | ||||||||||||||||
| Balance as of March 31, 2022 (unaudited) | 18,373,427 | 2,112 | 134,629 | 1,101 | ( 60,190 | ) | 77,652 | |||||||||||||||||
| Changes during the three months period ended June 30, 2022: | ||||||||||||||||||||||||
| Exercise of options | 7,625 | 1 | 49 | - | - | 50 | ||||||||||||||||||
| Stock based compensation | - | - | 697 | - | - | 697 | ||||||||||||||||||
| Net loss | - | - | - | - | ( 9,913 | ) | ( 9,913 | ) | ||||||||||||||||
| Balance as of June 30, 2022 (unaudited) | 18,381,052 | 2,113 | 135,375 | 1,101 | ( 70,103 | ) | 68,486 | |||||||||||||||||
| Balance as of December 31, 2020 | 14,587,934 | $ | 1,646 | $ | 70,361 | $ | 977 | $ | ( 37,497 | ) | $ | 35,487 | ||||||||||||
| Changes during the three months period ended March 31, 2021: | ||||||||||||||||||||||||
| Issuance of shares and warrants for cash consideration of $ 57,629 net of $ 4,455 issuance costs | 2,848,629 | 352 | 52,822 | - | - | 53,174 | ||||||||||||||||||
| Exercise of options | 13,435 | 2 | 38 | - | - | 40 | ||||||||||||||||||
| Exercise of warrants | 855,813 | 104 | 7,598 | - | - | 7,702 | ||||||||||||||||||
| Stock based compensation | - | - | 190 | - | - | 190 | ||||||||||||||||||
| Other comprehensive loss | - | - | - | ( 2,788 | ) | - | ( 2,788 | ) | ||||||||||||||||
| Net loss | - | - | - | - | ( 3,200 | ) | ( 3,200 | ) | ||||||||||||||||
| Balance as of March 31, 2021 (unaudited) | 18,305,811 | 2,104 | 131,009 | ( 1,811 | ) | ( 40,697 | ) | 90,605 | ||||||||||||||||
| Changes during the three months period ended June 30, 2021: | ||||||||||||||||||||||||
| Exercise of options | 375 | * | 2 | - | - | 2 | ||||||||||||||||||
| Stock based compensation | - | - | 652 | - | - | 652 | ||||||||||||||||||
| Other comprehensive loss | - | - | - | 2,055 | - | 2,055 | ||||||||||||||||||
| Net loss | - | - | - | - | ( 3,108 | ) | ( 3,108 | ) | ||||||||||||||||
| Balance as of June 30, 2021 (unaudited) | 18,306,186 | $ | 2,104 | $ | 131,663 | $ | 244 | $ | ( 43,805 | ) | $ | 90,206 |
accompanying notes are an integral part of the condensed consolidated financial statements.
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
dollars in thousands
| For the six months ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| Cash flows from operating activities | ||||||||
| Net (loss) | $ | ( 18,138 | ) | $ | ( 6,308 | ) | ||
| Adjustments required to reflect net cash used in operating activities: | ||||||||
| Income and expenses not involving cash flows: | ||||||||
| Depreciation | 364 | 239 | ||||||
| Non-cash operating lease expenses | 411 | 107 | ||||||
| Share-based compensation | 1,485 | 842 | ||||||
| Loss (income) on marketable securities and short-term bank deposits | 4,886 | ( 1,583 | ) | |||||
| Changes in operating asset and liability items: | ||||||||
| Decrease in prepaid expenses and other receivables | ( 205 | ) | ( 195 | ) | ||||
| Increase (decrease) in accounts payable trade | ( 211 | ) | 101 | |||||
| Increase (decrease) in accrued expenses and other liabilities | ( 307 | ) | 153 | |||||
| Operating lease liabilities | ( 827 | ) | ( 106 | ) | ||||
| Net cash (used in) provided by operating activities | ( 12,542 | ) | ( 6,750 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of property and equipment | ( 4,351 | ) | ( 472 | ) | ||||
| Release (investment) in short-term bank deposits | ( 35,234 | ) | 19,563 | |||||
| Purchases of marketable securities | ( 1,608 | ) | ( 85,695 | ) | ||||
| Proceeds from sales of marketable securities | 62,549 | 19,217 | ||||||
| Net cash provided by (used in) investing activities | 21,356 | ( 47,387 | ) | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of shares and warrants net of $ 4,455 issuance expenses | - | 53,174 | ||||||
| Proceeds from exercise of warrants | - | 7,702 | ||||||
| Proceeds from exercise of options | 100 | 42 | ||||||
| Net cash provided by financing activities | 100 | 60,918 | ||||||
| Increase (decrease) in cash and cash equivalents | 8,914 | 6,781 | ||||||
| Cash and cash equivalents - beginning of period | 11,636 | 7,012 | ||||||
| Exchange rate differences on cash and cash equivalents | - | ( 210 | ) | |||||
| Cash and cash equivalents - end of period | $ | 20,550 | $ | 13,583 | ||||
| Non-cash transactions: | ||||||||
| Warrants issued in settlement of issuance costs to a placement agent | $ | - | $ | 2,095 | ||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash paid for taxes | $ | - | $ | - | ||||
| Cash paid (received) for interest, net | $ | 45 | $ | 62 |
accompanying notes are an integral part of the condensed consolidated financial statements.
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)
Therapeutics R&D Ltd. ("Enlivex R&D") was incorporated in September 2005 under the laws of the State of Israel.
On March 26, 2019, upon consummation of a merger transaction between the Parent and Enlivex R&D, Enlivex R&D became a wholly
owned subsidiary of the Company.
January 2015, Enlivex Therapeutics Inc. was incorporated in the State of Delaware as a wholly owned subsidiary of the Parent.
June 21, 2021 Enlivex Therapeutics RDO Ltd. was incorporated in Israel as a wholly owned subsidiary of the Parent.
Company is a clinical stage macrophage reprogramming immunotherapy company, developing AllocetraTM, a universal, off-the-shelf
cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic
state is critical for immune system rebalancing and resolution of life-threatening conditions. Non-homeostatic macrophages contribute
significantly to the severity of certain diseases, which include solid tumors, sepsis and others.
is based on the discoveries of Professor Dror Mevorach, an expert on immune activity, macrophage activation and clearance of dying (apoptotic)
cells, in his laboratory in the Hadassah University Hospital located in the State of Israel.
Company's ordinary shares, NIS 0.40 per share ("Ordinary Shares"), are traded under the symbol "ENLV"
on both the Nasdaq Capital Market and on the Tel Aviv Stock Exchange.
Company devotes substantially all of its efforts toward research and development activities and raising capital to support such activities.
The Company's activities are subject to significant risks and uncertainties, including failing to secure additional funding before
the Company achieves sustainable revenues and profit from operations.
and development activities have required significant capital investment since the Company's inception. The Company expects that
its operations will require additional cash investment to pursue the Company's research and development activities, including preclinical
studies, formulation development, clinical trials and related drug manufacturing. The Company has not generated any revenues or product
sales and has not achieved profitable operations or positive cash flow from operations. The Company has incurred net losses since its
inception, and, as of June 30, 2022, had an accumulated deficit of $70,103 thousand.
Company expects to continue to incur losses for at least the next several years, and the Company will need to raise additional debt or
equity financing or enter into partnerships to fund its development. If the Company is not able to achieve its funding requirements,
it may be required to reduce discretionary spending, may not be able to continue the development of its product candidates or may be
required to delay its development programs, which could have a material adverse effect on the Company's ability to achieve its
intended business objectives. There can be no assurances that additional financing will be secured or, if secured, will be on favorable
terms. The ability of the Company to transition to profitability in the longer term is dependent on developing products and product revenues
to support its expenses.
Company's management and board of directors (the "Board") are of the opinion that the Company's current
financial resources will be sufficient to continue the development of the Company's product candidates for at least twelve months
from the filing of these financial statements on Form 6-K. The Company may determine, however, to raise additional capital during such
period as the Board deems prudent. The Company's management plans to finance its operations with issuances of the Company's
equity securities and, in the longer term, revenues. There are no assurances, however, that the Company will be successful in obtaining
the financing necessary for its long-term development. The Company's ability to continue to operate in the long term is dependent
upon additional financial support.
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2022 (UNAUDITED)
2 - SIGNIFICANT ACCOUNTING POLICIES
unaudited condensed consolidated financial statements include the accounts of the Company and have been prepared in accordance with U.S.
generally accepted accounting principles ("U.S. GAAP") for interim financial information. Accordingly, certain information
and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted.
In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation
unaudited condensed consolidated financial statements should be read in conjunction with the Company's audited annual financial
statements and notes thereto included in the Company's 2021 Annual Report on Form 20-F, as filed with the SEC on April 29, 2022.
The results of operations for these interim periods are not necessarily indicative of the operating results for any future period. The
December 31, 2021 financial information has been derived from the Company's audited financial statements.
preparation of interim financial statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and
assumptions that affect the reported amounts in the consolidated balance sheets and statements of operations, it also requires that management
exercise its judgment in applying the Company's accounting policies. On an ongoing basis, management evaluates its estimates, including
estimates related to its stock-based compensation expense and implicit interest rate on new lease liabilities. Significant estimates
in these interim financial statements include estimates made for accrued research and development expenses and stock-based compensation
Currency and Translation to The Reporting Currency
functional currency of the Company is the U.S. dollar because the U.S. dollar is the currency of the primary economic environment in
which the Company operates and expects to continue to operate in the foreseeable future.
September 30, 2021, the functional currency of Enlivex R&D was the New Israeli Shekel ("NIS").
related to non-monetary assets and liabilities are based on translated amounts as of the date of the change, and non-monetary assets
acquired and liabilities incurred after September 30, 2021 were translated at the approximate exchange rate prevailing at the date of
the transaction. Transactions included in the statement of income for the three and six month periods ended June 30, 2022 were translated
at the approximate exchange rate in effect at the respective times of the transactions. Transactions included in the statement of income
for the three and six month periods ended June 30, 2021 were translated at average exchange rates during the applicable period. Gains
or losses resulting from translation adjustments for the three and six month periods ended June 30, 2021 are reported in other comprehensive
U.S. dollar = 3.50 NIS and 3.11 NIS as of June 30, 2022 and December 31, 2021, respectively.
U.S. dollar increased (decreased) against the NIS: 10.20%, 12.54%, (2.22%) and 1.4% in the three and six month periods ended June 30,
2022 and 2021, respectively.
of Prior Year Presentation
prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on
the reported results of operations.
Adopted Accounting Standards
August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and
Hedging: Contracts in Entity's Own Equity (Subtopic 815-40) ("ASU 2020-06"). ASU 2020-06 simplifies the
complexity associated with applying GAAP for certain financial instruments with characteristics of liabilities and equity by removing
certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. The standard
also enhances the consistency of earnings-per-share calculations by requiring that an entity use the if-converted method and that
the effect of potential share settlement be included in diluted earnings-per-share calculations. ASU 2020-06 became effective for fiscal
years and interim periods within those fiscal years beginning after December 15, 2021. The Company evaluated ASU 2020-06 and determined
that its adoption did not have an impact on the Company's condensed consolidated financial statements and related disclosures.